FDA Grants J&J’s Tecvayli Accelerated Approval for Myeloma

The FDA has granted accelerated approval to Johnson & Johnson’s Tecvayli (teclistamab-cqyv) for the treatment of adult patients with relapsed or refractory multiple myeloma who previously received four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody.

Tecvayli is a bispecific antibody that is administered subcutaneously. The drug activates the immune system by binding to the CD3 receptor expressed on the surface of T-cells and to the B-cell maturation antigen expressed on the surface of multiple myeloma cells and some healthy B-lineage cells.

The accelerated approval was based on a phase 2 study that showed an overall response rate of 61.8 percent, with 28.2 percent of patients experiencing a complete response with no detectable tumor. The company must conduct a postmarket study to support ongoing approval.